November 2010

The FDA versus Personal Genetics Firms

There is no doubt that the information from personal genome sequencing is priceless. However, the opportunities and innovations offered by personal genomics come coupled with legitimate apprehension. For example, are there standards in place to protect the consumer and ensure the analytical and clinical validity of the data provided?


DNAThe Human Genome Project resulted in the identification and mapping of approximately 24,000 genes. This laid the foundation for genetic testing as we know it today. Within years of the project’s completion, personal genomics firms sprouted up across the world, offering customers the opportunity to get their entire genome, or portions of it, sequenced for a price. Companies like 23andMeNavigenicsdeCODEme and Pathway Genomics offer genome-sequencing tests directly to consumers over the internet, allowing them to gain information about their predisposition to certain diseases or conditions, pharmacogenomics, ancestral background, features and characteristics.

Medical Benefits of Personal Genomics

There is no doubt that the information from personal genome sequencing is priceless. For a few hundred to several thousand dollars and a vial of saliva, consumers get the opportunity to be more hands-on about their health. The data provided through these tests can inform people about genetic variations that could put them at risk for Alzheimer’s disease, Parkinson’s disease, breast cancer, muscular dystrophy and a slew of other conditions. It also can allow physicians to effectively tailor treatment plans based on pharmacogenomic assessments that give details about a patient’s ability to metabolize certain medications. The benefits of such genetic tests are innumerable.

Issues Surrounding the Industry

The opportunities and innovations offered by personal genomics come coupled with legitimate apprehension. For example, are there standards in place to protect the consumer and ensure the analytical and clinical validity of the data provided? Are the tests strictly informative and recreational, or are they medical devices? If these genetic screens are considered medical devices, should they be marketed over the internet directly to consumers or should this process require the involvement of a physician or a genetics expert?

Sparked by these issues and Pathway Genomics’ decision to begin selling saliva test kits right off the shelves of Walgreens stores, the U.S. Food and Drug Administration wrote letters to several personal genomics firms requiring premarket clearance of the genetic tests they provide because they are considered to be medical devices. By the FDA’s definition, a medical device is something that is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” Based on this definition, the FDA is requiring that the tests be subject to regulation.

The FDA also held a public meeting on “Oversight of Laboratory Developed Tests.” Based on transcripts of the two-day meeting, the agency appeared dedicated to being open, transparent and interested in the opinion of the public and vested in protecting consumers. Although the issues that are more pertinent to the direct-to-consumer personal genomics industry were not the general focus, several issues such as clinical validity and utility of LDTs, consumer privacy and consent were discussed.

Among the concerns mentioned was the direct access consumers have to genetic tests. Some argued that access should require the involvement of physicians or health care providers, suggesting that, without the involvement of physicians, consumers run the risk of making harmful, misinformed decisions. On the other side of the spectrum, heads of these firms argued that limiting consumer access by requiring the involvement of physicians would deprive customers of their right to know about their genetics and to become involved in their health.

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